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CN1326514A - Electrode strips for testing small volumes - Google Patents

Electrode strips for testing small volumes Download PDF

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Publication number
CN1326514A
CN1326514A CN99813160A CN99813160A CN1326514A CN 1326514 A CN1326514 A CN 1326514A CN 99813160 A CN99813160 A CN 99813160A CN 99813160 A CN99813160 A CN 99813160A CN 1326514 A CN1326514 A CN 1326514A
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CN
China
Prior art keywords
test strip
electrode
analyte
enzyme
liquid
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN99813160A
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Chinese (zh)
Inventor
B·永金
J·麦克坎恩
N·布莱尔
L·J·考克斯
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cambridge Sensors Ltd
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Cambridge Sensors Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cambridge Sensors Ltd filed Critical Cambridge Sensors Ltd
Publication of CN1326514A publication Critical patent/CN1326514A/en
Pending legal-status Critical Current

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    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/54Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving glucose or galactose
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/001Enzyme electrodes
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/001Enzyme electrodes
    • C12Q1/005Enzyme electrodes involving specific analytes or enzymes
    • C12Q1/006Enzyme electrodes involving specific analytes or enzymes for glucose

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  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • General Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Microbiology (AREA)
  • Molecular Biology (AREA)
  • Analytical Chemistry (AREA)
  • Biotechnology (AREA)
  • Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Emergency Medicine (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Battery Electrode And Active Subsutance (AREA)
  • Investigating Or Analyzing Materials By The Use Of Electric Means (AREA)
  • Investigating Or Analysing Materials By The Use Of Chemical Reactions (AREA)
  • Eye Examination Apparatus (AREA)
  • Polishing Bodies And Polishing Tools (AREA)

Abstract

一种测试条,其包括承载有效电极和对电极的支持体和一层材料,待测的小体积液体可以分布在所说的材料层内并且提供电极之间的接触,并且其中材料上涂布有分析物特异性试剂。材料层可以以带的方式方便提供,从中可以切割部分或顺序使用。A test strip comprising a support carrying an active electrode and a counter electrode and a layer of material in which a small volume of liquid to be tested can be distributed and provides contact between the electrodes, and wherein the material is coated There are analyte-specific reagents. Layers of material are conveniently provided in strips, from which sections can be cut or used sequentially.

Description

The electrode strip that is used for testing small volumes
Invention field
The present invention relates to be used for the electrode strip of for example whole blood of testing small volumes.
Background of invention
Diabetes are a kind of modal endocrinopathys.The patient is their blood-glucose content of monitoring constantly.Usually to realize by using the little test strip that detects blood-glucose.
The most normal problem that runs into of test strip user is that the blood flow volume on the test strip is improper and the layout of blood on test strip is improper.A lot of devices tackle this problem by the sample chamber of using capillary action to fill.Sample is retained near the electrode, promotes the mensuration of specific analyte in the sample; Referring to EP-A-0170375 and US-A-5141868.
This class known device comprises the electrode that is deposited on the non-conductive substrate, be coated with on the electrode be specific at the reagent system of analyte and be contained in the cavity, the size of this cavity is small enough to permission and introduces for example sample of 2.5-3 μ L of volume by capillary action.The compact degree of these devices is subjected to manufacturing tolerance and by the restriction of its chemical attainable signal to noise ratio.
US-5820551 discloses a kind of test strip, and it comprises the carrying working electrode and to the support of electroplax and be coated on enzyme and amboceptor on the active electrode.Whole blood just can provide the conducting path between the electrode, and can measure the glucose concn in the blood.Active electrode contacts with whole blood sample, between do not insert film or other whole blood filter.
WO-A-98/55856 (open after the application's priority date) discloses a kind of analyte specific reagent that is coated on the conducting stratum, and is positioned at reagent and the monofilament screen cloth above the reference electrode.The sample administration zone is provided at an edge of screen cloth.
Summary of the invention
First aspect of the present invention is a kind of test strip, it comprises the support and the layer of material of carrying active electrode and counter electrode, small volumes of liquids to be measured can be distributed in the said material layer and contact between the electrode is provided, and wherein be coated with the analyte specific reagent on the material, as a kind of component of redox reaction, for example enzyme, cofactor or amboceptor.Specifically, the invention provides a kind of test strip that is used for blood-glucose, wherein the demand of sample is considerably less, and by using reagent to realize effective reaction kinetics in new ways.
The material of reagent coating itself can be belt-like form.The flexibility band that second aspect of the present invention is material, liquid can be distributed in wherein and zone of dispersion thereon is coated with at least a component of redox reaction.
Invention is described
Among the present invention, any or various ingredients of redox reaction, for example enzyme (as notatin or glucose dehydrogenase), cofactor and amboceptor can be applied on the screen cloth or film that is placed on device top.Only for illustrational purpose, the present invention can be described as a reference with the screen cloth of enzyme coating.No matter use which kind of component or which component, when adding sample, they dissolve rapidly and form effective reaction medium, and this reaction medium can provide the contact between the test strip discrete electrodes.In this mode, diffusion barrier can be carried out and not have to reaction fast.This reaction type is low at sample volume, sample glues (as whole blood) and require in the quick response situation necessary especially.
In a typical embodiments of the present invention, the sensing member test strip is made up of two electrodes, one of them play the working electrode effect and another play oppositely, the reference electrode effect.The end of the working electrode that contacts with sample have one with its amboceptor that closely contacts.Test strip provides effectively by these two reaction chambers that electrode and additional lamella limited, and wherein said lamella overlays on above the electrode, and its precoating has the cofactor of any necessity of oxydo-reductase and enzyme.Reaction chamber can also comprise other sheet of material and/or wetting agent such as tensio-active agent or molten born of the same parents' material (it can be positioned on any one deck and cover in the lamella).In this way, organized enzyme is not coated on the conductor that forms working electrode but is provided in the above the separating layer, and this separating layer effectively forms the solution phase of reaction chamber again.When combining, can set up and approach in stirring reaction chamber, to carry out effective blended condition with lateral flow.
In an example of the present invention, silver chloride/silver-colored reference/counter electrode is placed on and is adjacent to carbon electrode.In general, for this purpose, a pair of printing carbon electrode is printed on the non-conductive substrate, silver/silver chloride is printed on makes it play the function of reference/counter electrode on one of them carbon electrode then.With non-conducting ink printing at carbon electrode with above the substrate so that determine in each electrode a part as on the contact mat that is used to insert gauger and each electrode away from another part of contact mat as the sensing unit that receives sample.
Then, preparation is used for the amboceptor of enzyme cofactor NADH, and by move liquid with its from the aqueous solution deposition to the electrode on.On working electrode, deposit the layer that another contains NAD then.
Give monofilament screen material coating surface promoting agent by moving spraying of liquid, printing ink or dip-coating, coating contains the solution of glucose dehydrogenase then, and be positioned over two electrodes above, form reaction chamber.This reaction chamber can also form the cavity that fill at the edge by additional printing or by using top layer to limit.For example, second kind of non-conducting ink printing at the top of screen material, applied a cover tape at the screen cloth top then in some way, so that stay enlarged area for the screen cloth of using the sample exposure.
This device allows the sample of small volume (in general be 1 μ L or still less) is applied to the extension of screen cloth.Next use the sensing unit of the exuberant device of sample, it is closely contacted with the mensuration electrode.
Unit describe with edge filling is in WO-A-98/55856.The present invention can simply change a social system them once.Specifically, can be with reference to Fig. 1 of WO-A-98/55856; Assembly of the present invention is support (1), electrode (2/3), screen material (6) and band (7); In addition, on screen material, provide reagent.This device can be worked by its edge is applied to sample.When sample was difficult to extract, it was valuable especially.Other structure is apparent to those skilled in the art, comprises being applied to the combination of covering one or more cofactors, amboceptor or enzyme on screen cloth or the membrane layer.The selection of various combinations can be depending on the reaction kinetics of all cpds.
In another embodiment of this device, enzyme or amboceptor are coated on the lamella, cofactor and other amboceptor or enzyme directly are coated on the working electrode, and lamella can filtering whole blood, so that active electrode detects the sample that does not effectively contain complete blood cell.At this moment, reduced result's hematocrit dependence basically.In this way, the rapid kinetics that has some or all reactive behavior compositions (enzyme, amboceptor and cofactor) in the filter born of the same parents function that can make selected film and the film combines, and obtains device efficiently.
In a word, device of the present invention makes up by needed one or more reagent of analyte quantitative analysis being deposited as individual layer or answering layer on fine screen mesh material or film; The size of deposition region is small enough to very the sample of small volume just can be wetting.This screen cloth or film both can also can use in electrochemical appliance in colorimetric device.
One of the present invention is characterised in that reagent accurately is coated on the target area of textile materials such as polyester or nylon or other porous-film.During use, it is provided at the quick dissolving of reagent under the existence of sample.A kind of reagent or plurality of reagents can be applied to obtain in accurate location with in clear and definite impression in the different methods of deposition known volume.Comprise the use partitioning device, as piston pump, syringe pump or request formula ink-jet printer.
In another embodiment, can be with the flexibility band that contains one or more reagent and the another kind of flexible tape lamination that is printed with a series of electrodes on it.The laminate that can use in order (containing a row or an a series of sensing member) is for example distributed by suitable divider, replaces cutting out single sensing member.For this purpose, no matter whether be laminate, the form of a band of the present invention with volume can be provided, and leave in the cartridge (cassette) of sealing, can also contain siccative in this cartridge.During use, cartridge can be inserted in the automatic dispenser, therefrom automatically the roll coil of strip be opened by indexing mechanism, order is exposed discrete sensing member.Therefore, the effect of this instrument is similar to the effect of photographic camera film.In this embodiment, band can also contain erythrolysis reagent such as saponin(e, so that reduce hematocrit and oxyphorase effect in the whole blood sample.Band can also further be avoided moisture effects by covering with the film (as the aluminium film) that can peel off, and divides timing when being with from cartridge, and the film that can peel off is peeled off automatically.When with sample administration during in sensing member, electrochemically in the working sample at the amount of analyte.This mensuration can be undertaken by currently known methods.
Following embodiment will illustrate the present invention.
Embodiment
By silk screen print method the conductive ink material is printed on the non-conducting polyester sheet layer material.The conductive ink material is made up of graphite and carbon granule and the mixture that is dissolved in the polymer binder of organic solvent.After treating the conductivity ink deposition, in forcing air oven, remove and desolvate.Silver/silver chloride reference/counter electrode is printed onto on the electrode of every pair of printing carbon electrode, then republishes non-conducting ink lay, so that determine contact mat and sensing member district.
To deposit on the carbon electrode such as amboceptor or other suitable dyestuff and the enzyme cofactor Reduced nicotinamide-adenine dinucleotide (NAD) of Meldola Blue, Nile Blue.Perhaps, with NAD by aqueous ink separately be coated to amboceptor above.
The form of enzyme glucose dehydrogenase with uniform round dot is deposited on the monofilament polyester screen cloth band.It can followingly obtain:
(a) in contact mode, allow the drop that is in close proximity to screen cloth that forms at the divider top end be transferred on the screen cloth by drop being touched screen surface; Perhaps
(b) in noncontact mode, the drop that allows ink jet printing head above the screen cloth or other hole form never can cause its distance that is seeped in the screen cloth to drip on the screen cloth
After the drying, round dot spreads and covers a zone, and this area part is determined by application conditions by screen cloth braiding feature and part.In general, the zone of 500nL drop covering is 1.3 * 1.2mm.Make the screen cloth band at room temperature dry.
Then, will further protect on the modification lamella of the screen cloth tape lamination auto levelizer of enzyme-modified and by non-conduction printing.Finally, cover tape is laminated to the top of screen cloth.The device lamella cuts conglobate single assembly.In another device form, laminated lamella rolled and the cartridge type unit of packing in, by being similar to the winding machinery of photographic camera film winding system, allow to use one device.

Claims (11)

1.一种测试条,其包括承载有效电极和对电极的支持体和一层材料,待测的小体积液体可以分布在所说的材料层内并且提供电极之间的接触,并且其中材料上涂布有分析物特异性试剂。1. A test strip comprising a support carrying an active electrode and a counter electrode and a layer of material in which a small volume of liquid to be tested can be distributed and contact between the electrodes is provided, and wherein the material is Coated with analyte-specific reagents. 2.根据权利要求1的测试条,其中试剂是氧化还原反应的至少一种组分,例如一种或多种酶、酶用介体和/或辅因子。2. The test strip according to claim 1, wherein the reagent is at least one component of a redox reaction, such as one or more enzymes, mediators for enzymes and/or cofactors. 3.根据权利要求2的测试条,其中该至少一种组分包括酶。3. The test strip according to claim 2, wherein the at least one component comprises an enzyme. 4.根据权利要求2或3的测试条,其中酶是葡糖氧化酶或葡糖脱氢酶。4. A test strip according to claim 2 or 3, wherein the enzyme is glucose oxidase or glucose dehydrogenase. 5.根据前述权利要求任一项的测试条,其中材料是单丝筛网或膜。5. A test strip according to any one of the preceding claims, wherein the material is a monofilament mesh or membrane. 6.一种材料的柔性带,液体可以分布在其中并且在其上的离散区域涂布有氧化还原反应的至少一种组分。6. A flexible strip of material in which a liquid can be distributed and on which discrete areas are coated with at least one component of a redox reaction. 7.根据权利要求6的柔性带,其中材料是单丝筛网或膜。7. A flexible belt according to claim 6, wherein the material is a monofilament screen or film. 8.一种装有被卷起的权利要求6或7的带的容器。8. A container containing the tape of claim 6 or 7 rolled up. 9.根据权利要求8的容器,还包括自动分配装置。9. The container of claim 8, further comprising an automatic dispensing device. 10.一种测试液体以便检测分析物存在的方法,包括将液体与权利要求1-5任一项的测试条接触,并且检测电流。10. A method of testing a liquid to detect the presence of an analyte comprising contacting the liquid with a test strip according to any one of claims 1-5 and detecting an electrical current. 11.根据权利要求10的方法,其中液体是血液并且分析物是葡萄糖。11. The method according to claim 10, wherein the fluid is blood and the analyte is glucose.
CN99813160A 1998-11-11 1999-11-11 Electrode strips for testing small volumes Pending CN1326514A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB9824627.5 1998-11-11
GBGB9824627.5A GB9824627D0 (en) 1998-11-11 1998-11-11 Test strips for small volumes

Publications (1)

Publication Number Publication Date
CN1326514A true CN1326514A (en) 2001-12-12

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CN99813160A Pending CN1326514A (en) 1998-11-11 1999-11-11 Electrode strips for testing small volumes

Country Status (12)

Country Link
EP (1) EP1129211B1 (en)
JP (1) JP2002529717A (en)
KR (1) KR20010092723A (en)
CN (1) CN1326514A (en)
AT (1) ATE244767T1 (en)
AU (1) AU1063900A (en)
BR (1) BR9915211A (en)
CA (1) CA2351066A1 (en)
DE (1) DE69909503T2 (en)
ES (1) ES2203202T3 (en)
GB (1) GB9824627D0 (en)
WO (1) WO2000028068A1 (en)

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CN105556299A (en) * 2013-09-11 2016-05-04 西拉格国际有限责任公司 Electrochemical-based analytical test strip with ultra-thin discontinuous metal layer
CN107664658A (en) * 2016-07-27 2018-02-06 希森美康株式会社 Electrode and manufacture method, enzyme/glucose sensor and biotic component measure device

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CN105556299A (en) * 2013-09-11 2016-05-04 西拉格国际有限责任公司 Electrochemical-based analytical test strip with ultra-thin discontinuous metal layer
CN107664658A (en) * 2016-07-27 2018-02-06 希森美康株式会社 Electrode and manufacture method, enzyme/glucose sensor and biotic component measure device

Also Published As

Publication number Publication date
EP1129211B1 (en) 2003-07-09
EP1129211A1 (en) 2001-09-05
WO2000028068A1 (en) 2000-05-18
GB9824627D0 (en) 1999-01-06
ES2203202T3 (en) 2004-04-01
DE69909503T2 (en) 2004-01-29
BR9915211A (en) 2001-10-30
KR20010092723A (en) 2001-10-26
AU1063900A (en) 2000-05-29
DE69909503D1 (en) 2003-08-14
ATE244767T1 (en) 2003-07-15
CA2351066A1 (en) 2000-05-18
JP2002529717A (en) 2002-09-10

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